Trials / Recruiting
RecruitingNCT06708468
Personalized Training for People With Rare Neuromuscular Disorders
Personalized Exercise Training for People With Rare Neuromuscular Disorders: a Multi-center, Evaluator-blinded, Two Arm, Randomized Controlled Study to Assess the Effects on Physical Function From Personalized Strength and Balance Exercise in a Rehabilitation Setting.
- Status
- Recruiting
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 120 (estimated)
- Sponsor
- Oslo University Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years – 70 Years
- Healthy volunteers
- Not accepted
Summary
The goal of this study is to investigate the effects of personalized exercise treatment on dynamic balance and physical function in comparison with regular follow-up in adults with rare-neuromuscular disorders: Charcot-Marie-Tooth (CMT), Facioscapulohumeral Muscular Dystrophy (FSHD), and Myotonic Dystrophy Type 1 (DM1). The key objectives are: 1. To investigate if the intervention group experiences improvements in dynamic balance that are superior to the control group 2. To investigate if the intervention group experiences long-term improvements in dynamic balance that are superior to the control group during the follow-up 3. To investigate if improvements in dynamic balance are associated with improvements in physical activity, body composition, estimated motor units, metabolomics, muscle echnogenecity and volume, and other indicators of health and quality of life. This is a national study and will involve 120 individuals with rare-neuromuscular disorders from Norway's four health regions.
Conditions
- Neuromuscular Diseases (NMD)
- Charcot Marie Tooth Disease (CMT)
- Facioscapulohumeral Muscular Dystrophy
- Myotonic Dystrophy Type 1 (DM1)
Interventions
| Type | Name | Description |
|---|---|---|
| OTHER | Exercise | The intervention includes 12-day personalized exercise program set in a rehabilitation center, followed by a three-month digital intervention and then a second 12-day personalized exercise program in a rehabilitation center. |
| OTHER | Usual Care | Usual care includes appointments at hospitals and in the community health system according to what has been recommended to that individual |
Timeline
- Start date
- 2024-12-13
- Primary completion
- 2026-12-01
- Completion
- 2028-12-01
- First posted
- 2024-11-27
- Last updated
- 2025-04-27
Locations
5 sites across 1 country: Norway
Source: ClinicalTrials.gov record NCT06708468. Inclusion in this directory is not an endorsement.